Effekt, immunogenicitet og sikkerhedsundersøgelse af 9vHPV-vaccinen hos japanske mænd (V503-064)
18. maj 2026 opdateret af: Merck Sharp & Dohme LLC
Et fase 3, randomiseret, placebokontrolleret klinisk studie til evaluering af effektiviteten, immunogeniciteten og sikkerheden af 9vHPV-vaccinen hos japanske mænd i alderen 16 til 26 år.
Formålet med denne fase 3, dobbeltblindede, placebokontrollerede kliniske undersøgelse er at evaluere effektiviteten af V503 (9-valent human papillomavirus [9vHPV] vaccine) til at forhindre HPV-relateret anogenital vedvarende infektion og at evaluere sikkerheden/tolerabiliteten af V503, hos japanske mænd, der er 16 til 26 år.
Det er en hypotese, at administration af et 3-dosis regime af V503 reducerer den kombinerede forekomst af HPV 6/11/16/18-relateret anogenital vedvarende infektion, såvel som den kombinerede forekomst af HPV 31/33/45/52/58- relateret anogenital vedvarende infektion sammenlignet med placebo.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1059
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Osaka, Japan, 542-0073
- Iwasa Clinic ( Site 6411)
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Osaka, Japan, 542-0076
- Nomura Clinic Namba ( Site 6405)
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Osaka, Japan, 542-0086
- Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)
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Osaka, Japan, 553-0001
- Yamanaka Clinic ( Site 6410)
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Tokyo, Japan, 101-0041
- Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)
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Tokyo, Japan, 103-0014
- Yuge Clinic ( Site 6421)
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Tokyo, Japan, 107-0052
- Taisei Clinic ( Site 6403)
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Tokyo, Japan, 120-0034
- Mildix Skin Clinic ( Site 6423)
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Tokyo, Japan, 125-0041
- Sugisawa Dermatology Clinic ( Site 6422)
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Tokyo, Japan, 132-0011
- Medical Corporation Sanshikai Toru Clinic ( Site 6401)
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Tokyo, Japan, 144-0051
- Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418)
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Tokyo, Japan, 154-0024
- Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)
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Tokyo, Japan, 158-0097
- Naoko Dermatology Clinic ( Site 6417)
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Tokyo, Japan, 160-0022
- Medical Corporation Iseikai My City Clinic ( Site 6414)
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Tokyo, Japan, 160-0022
- Shinjuku Higashiguchi Clinic ( Site 6415)
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Tokyo, Japan, 167-0051
- Ogikuboekimae Clinic ( Site 6413)
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Tokyo, Japan, 175-0092
- Kusunoki Clinic ( Site 6412)
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Gunma
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Takasaki, Gunma, Japan, 370-0826
- Umeyama Clinic ( Site 6406)
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Kanagawa
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Kawasaki, Kanagawa, Japan, 210-0852
- Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)
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Yokohama, Kanagawa, Japan, 231-8331
- Ocean Clinic ( Site 6407)
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Osaka
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Sakai, Osaka, Japan, 590-0024
- Kanno Clinic ( Site 6402)
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Tokyo
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Hachiōji, Tokyo, Japan, 192-0071
- P-One Clinic, Keikokai Medical Corp. ( Site 6419)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 26 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Er en japansk mand i alderen 16 til 26 år
- Har ikke mere end 5 livslange seksuelle partnere
Ekskluderingskriterier:
- Har tidligere kendt vaccination med en HPV-vaccine eller planlægger at modtage en uden for undersøgelsen
- Har en historie med eksterne kønsvorter
- Har en historie med alvorlig allergisk reaktion, der krævede medicinsk indgriben
- Har modtaget immunglobulin eller blod-afledte produkter inden for de seneste 3 måneder eller planlægger at modtage nogen før måned 7 af undersøgelsen
- Har en historie med splenektomi, er i øjeblikket immunkompromitteret eller er blevet diagnosticeret med immundefekt, human immundefektvirus (HIV), lymfom, leukæmi, systemisk lupus erythematosus, reumatoid arthritis, juvenil reumatoid arthritis, inflammatorisk tarmsygdom eller anden autoimmun tilstand
- Har modtaget immunsuppressiv behandling inden for det seneste år, undtagen inhalerede, nasale eller topikale kortikosteroider og visse regimer af systemiske kortikosteroider
- Har en kendt trombocytopeni eller koagulationsforstyrrelse, der ville kontraindicere intramuskulære injektioner
- Har et igangværende alkohol- eller stofmisbrug inden for de seneste 12 måneder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: V503
In the base study, participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
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9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 viruslignende partikel (VLP) 30/40/60/40/20/20/20/20/20/20 mcg pr. dosis.
Andre navne:
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Placebo komparator: Placebo
In the base study, participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
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0,9% natriumchlorid (NaCL)
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Eksperimentel: V503 → Open Label V503 Extension Study
Participants from V503 arm of the base study who do not complete the 3-dose series receive 1 or 2 doses of V503, on Day 1, or Day 1 and Month 4 of the open label extension study.
|
9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 viruslignende partikel (VLP) 30/40/60/40/20/20/20/20/20/20 mcg pr. dosis.
Andre navne:
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Eksperimentel: Placebo → Open Label V503 Extension Study
Participants from the placebo arm of the base study receive 3 doses of V503 on Day 1, Month 2 and Month 6 of the open label extension study.
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9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 viruslignende partikel (VLP) 30/40/60/40/20/20/20/20/20/20 mcg pr. dosis.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Base Study: Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection
Tidsramme: Up to approximately 36 Months
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Combined incidence of HPV type(s) 6/11/16/18-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least one applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least one applicable HPV type(s) in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease.
Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms.
Per protocol, cases per 100 person-years is reported for applicable HPV type eligible participants with data available in the per-protocol efficacy population (PPE).
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Up to approximately 36 Months
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Base Study: Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Tidsramme: Up to 5 days after any vaccination
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination.
The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, tenderness/pain, and swelling) is reported here for all randomized participants in the All Participants as Treated (APaT) population.
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Up to 5 days after any vaccination
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Base Study: Percentage of Participants With ≥1 Systemic AE
Tidsramme: Up to 15 days after any vaccination
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The percentage of participants who experienced at least 1 systemic AE is reported here for all randomized participants in the All Participants as Treated (APaT) population.
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Up to 15 days after any vaccination
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Base Study: Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
Tidsramme: Up to approximately 37 months
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An SAE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is another important medical event.
The percentage of participants who experienced at least 1 SAE is reported here for all randomized participants in the All Participants as Treated (APaT) population.
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Up to approximately 37 months
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Base Study: Number of Participants With Elevated Oral Body Temperature
Tidsramme: Up to 5 days after any vaccination
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Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days.
The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded using the vaccination report card (VRC).
Per protocol, fever was defined as an oral temperature of ≥99.5°F(37.5°C).
The number of participants who had at least 1 oral body temperature reading that was, <99.5°F (<37.5ºC),
≥99.5°F (≥37.5ºC) and <100.4°F
(38.0°C), or ≥100.4°F
(38.0°C) and <101.3°F(38.5°C),
or ≥101.3°F(38.5°C) is reported here for all randomized participants in the APaT population with temperature data available.
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Up to 5 days after any vaccination
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Base Study: Combined Incidence of HPV 31/33/45/52/58-related Anogenital Persistent Infection
Tidsramme: Up to approximately 36 Months
|
Combined incidence of HPV type(s) 31/33/45/52/58-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least 1 applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least 1 applicable HPV type in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease.
Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms.
Per protocol, cases per 100 person-years is reported for applicable HPV type(s) eligible participants with data available in the per-protocol efficacy population (PPE).
|
Up to approximately 36 Months
|
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Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Tidsramme: Month 7
|
Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA).
Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL).
Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for all randomized participants of the per-protocol immunogenicity population (PPI).
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Month 7
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Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Tidsramme: Month 7
|
Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA).
Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL).
Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for the heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).
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Month 7
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Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Tidsramme: Month 7
|
Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA).
Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL).
Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for the males who have sex with males (MSM) subgroup of the per-protocol immunogenicity population (PPI).
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Month 7
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Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Tidsramme: Month 7
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Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples.
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type.
The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31.
The percentage of participants with seroconversion is reported for both V503 and Placebo for all randomized participants of the per-protocol immunogenicity population (PPI).
|
Month 7
|
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Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Tidsramme: Month 7
|
Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples.
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type.
The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31.
The percentage of participants with seroconversion is reported for both V503 and Placebo for the heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).
|
Month 7
|
|
Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Tidsramme: Month 7
|
Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples.
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type.
The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31.
The percentage of participants with seroconversion is reported for both V503 and Placebo for the males who have sex with males (MSM) subgroup of the per-protocol immunogenicity population (PPI).
|
Month 7
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. november 2020
Primær færdiggørelse (Faktiske)
31. december 2023
Studieafslutning (Faktiske)
23. juli 2025
Datoer for studieregistrering
Først indsendt
5. november 2020
Først indsendt, der opfyldte QC-kriterier
13. november 2020
Først opslået (Faktiske)
19. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Patologiske processer
- Neoplasmer efter sted
- Neoplasmer
- Sygdomsegenskaber
- Tarmsygdomme
- Infektioner
- Virussygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Endetarmssygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- DNA-virusinfektioner
- Hudsygdomme
- Hudsygdomme, smitsom
- Tumorvirusinfektioner
- Hudsygdomme, viral
- Anus sygdomme
- Papillomavirus infektioner
- Rektale neoplasmer
- Vorter
- Patologiske tilstande, tegn og symptomer
- Hud- og bindevævssygdomme
- Anus neoplasmer
- Condylomata Acuminata
- Immunologiske faktorer
- Lægemidlers fysiologiske virkninger
- Vacciner
Andre undersøgelses-id-numre
- V503-064 (Anden identifikator: MSD Protocol Number)
- jRCT2031200217 (Registry Identifier: jRCT)
- 2020-001047-67 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .